Clinical Trial

Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness

Active, Not Recruiting
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Summary
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-center trial with a long-term follow-up (up to 24-months) of study participants.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2022-05-01; most recent amendment 2026-05-27.
Status change: Recruiting → Active, Not Recruiting 2026-05-27
Status change: Enrolling by Invitation → Recruiting 2025-06-11
Status change: Not Yet Recruiting → Enrolling by Invitation 2022-08-30
Trial Details
NCT Number NCT05362370
Lead Sponsor Stryker Craniomaxillofacial
Collaborators: Qmed Consulting A/S
Conditions Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries
Enrollment 99 participants
Start Date 2023-02-01
Primary Completion 2026-11-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-29